Unlike Mainland China’s NMPA (formerly CFDA) risk-based classification (Class I to III), Hong Kong currently operates under the – a voluntary but widely adopted framework.
Hong Kong utilizes a four-tier classification system for IVD medical devices, ranging from Class A (lowest risk) to Class D (highest risk). This system aligns with international principles established by the International Medical Device Regulators Forum (IMDRF). Risk Level Example Devices Low Individual & Public Health Risk hong kong ivd classification
If you’re involved in bringing In Vitro Diagnostic (IVD) devices to the Hong Kong market, understanding the local classification system is your first critical step. Risk Level Example Devices Low Individual & Public
Vitamin B12 tests, pregnancy self-testing kits, or cholesterol tests. High Individual / Moderate Public Health Risk The kit was designed for single-use and had
Lena, a medical device manufacturer, developed a simple IVD test kit for self-monitoring blood glucose levels. The kit was designed for single-use and had a straightforward testing procedure. After reviewing the product's specifications and intended use, the MDCO classified it as a Class A device, which carries the lowest risk. As a Class A device, the test kit required minimal regulatory documentation and was subject to a simple registration process.